"It's Deplorable"

More criticism of the Cypher stent ad campaign appears in the New York Times.

Such an initiative is so pernicious and wasteful (can you say, "expensive?") at a time when doctors and patients are being squeezed by corporate interests over healthcare delivery that I hope this ad becomes a battle cry to steer patient's away from their device.

Why do you think Medtronic quietly buried their direct-to-consumer ad campaign? (Hint: It wasn't just because of lead recalls. Referring doctors, seeing the avaricious nature of such a campaign, revolted as well.)

-Wes

More Direct-to-Consumer Insanity

Now it's Johnson and Johnson's turn: starting on Thanksgiving Day, coronary stent (specifically Cypher stent) advertisements began airing on television directly to "consumers," our patients, promoting the ability of stents to "prop up your life" that has been "narrowed" by coronary blockages. "Life wide open" is the tag line.

It's so catchy. As though our patients can go down to the corner store and pick one of these up for their heart. I guess J&J feels patients can discern when a drug-eluting stent is preferred over a bare metal stent, or better yet: when a stent is appropriate and when it is not. Why didn't their ad mention that other non-invasive options might be more appropriate before stenting in some circumstances?

Well, it's simple. The best medical care isn't important to J&J. What is important is that J&J sells more stents. To that end, what's really important to J&J is that patients ask their doctors why their life isn't "wide open" and full throttle yet. As if we don't have better things to discuss.

But I guess J&J figures our patients' wallets are wide open, given the cost of such advertising, especially in prime-time TV slots. This advertising, by the way, is in addition to an already re-worked website and other print media that has appeared in major newspapers.

And J&J seems to be taking a path that is in direct conflict with their own credo, their guiding mission statement, that has hung on their walls for over 60 years:

"We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services. In meeting their needs everything we do must be of high quality. We must constantly strive to reduce our costs in order to maintain reasonable prices."

And where's the FDA who promised to monitor such advertising to our patient "consumers?"

Oh, I forgot - they're enjoying "monitoring" the commercials with a beer in their hand in front of the TV.

-Wes

Image credit.

St. Jude and J&J?

Oh boy, the rumor mill's a churnin'.

-Wes

CMS Could Retrict Payment for Drug-Eluting Stents

The Center of Medicare and Medicaid Services (CMS) is considering limiting reimbursement strategy for drug-eluting stents that are placed "off-label," like diabetics and those who having heart attacks. According to the Wall Street Journal this AM:

..."the Centers for Medicare & Medicaid Services, or CMS, says it is considering reopening its decision about how broadly to cover the stents. An agency spokesman said such a process, known as a National Coverage Determination, could result in restricting coverage of the stents to FDA-approved uses, keeping coverage the same, or something in between.

This could spell more bad news for Johnson and Johnson and Boston Scientific if further cuts in reimbursement for drug-eluting stents are implemented.

Almost on cue, data from a single-center observational study were published earlier this week in the American Journal of Cardiology that suggested that drug-eluting stents might be superior to bare metal stents in such "off-label" patients:

Abstract: In clinical trials of highly selected patients, drug-eluting stents (DESs) decreased restenosis but not the rate of acute myocardial infarction (AMI) or death. Whether DES use has an affect on the rate of AMI or death in unselected patients is uncertain. Bare metal stents (BMSs) were placed in 1,164 consecutive patients in the year before the introduction of DESs. DESs were subsequently placed in 1,285 consecutive comparable patients at Wake Forest Baptist Medical Center. Early and late clinical outcomes were compared. Propensity score analysis was used to adjust outcomes for baseline differences. Patient and procedural characteristics of the 2 groups were similar, with an overall incidence of 72% for acute coronary syndromes (p = NS). At 9 months, target vessel revascularization (2.8% vs 8.6%, p <0.001), AMI (3.7% vs 4.7%, p = 0.257), and death (4.9% vs 7.1%, p = 0.030) were lower in the DES group than in the BMS group. Propensity score-adjusted Cox proportional hazard ratios for DES versus BMS at 9 months were 0.71 (95% confidence interval 0.42 to 1.19) for AMI, 0.56 (95% confidence interval 0.36 to 0.87) for death, and 0.60 (95% confidence interval 0.42 to 0.86) for the combined end point of AMI or death. In conclusion, in this single-center observational study, use of DESs in consecutive unselected patients, most of whom would not have been eligible for inclusion in the randomized trials of DES versus BMS, was associated with lower AMI and death rates than in a comparable group of patients treated with BMSs in mid-term (9-month) follow-up.

This study was sponsored by Johnson and Johnson. What the effect on long-term clopidogrel therapy, recently recommended to prevent the late in-stent thrombosis of drug-eluting stents has on these "off-label" patients, especially after nine months (when in-stent thrombosis is seen), remains untested. Look for significant positioning by these companies to continue the status quo.

-Wes

References: Robert J. Applegate, Matthew T. Sacrinty, Michael A. Kutcher, Talal T. Baki, Sanjay K. Gandhi, Renato M. Santos and William C. Little, Comparison of Drug-Eluting Versus Bare Metal Stents on Later Frequency of Acute Myocardial Infarction and Death, The American Journal of Cardiology, Volume 99, Issue 3, 1 February 2007, Pages 333-338.

Keith Winstein, "Agency Reviews Stent Coverage," Wall Street Journal (Subscription), 6 February 2007, Page D4.